John Mason, Martin Kraft, Jakob Hueckels, Hao Wei, Konstantinos Spetsieris
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引用次数: 0
Abstract
Cell therapies represent a transformative approach for treating diseases resistant to conventional therapies, yet their development and manufacturing face significant hurdles within the biopharmaceutical sector. A critical parameter in the production of these therapies is cell confluency, which serves as both an indicator of biomass in adherent cultures and a determinant of product quality. However, existing methods for measuring confluency are often inadequate for the large-scale cultivation systems used in industry, and current software solutions lack comprehensive automation capabilities necessary for a manufacturing environment. This article introduces a novel image-based software application designed for accurate cell confluency estimation, integrated with a high-throughput microscopy system. Utilizing a machine-learning model for pixel classification, the application facilitates efficient image and metadata processing in a cloud environment, delivering results through an interactive web interface. By incorporating methods from process analytical technologies, manufacturing data digitalization, and data science, this platform enables automated image acquisition, storage, analysis, and reporting in near-real time. The proposed solution aims to streamline the manufacturing process of cell therapeutics, ultimately enhancing the reliability and speed of delivering these innovative treatments to patients.
期刊介绍：
The translation of new discoveries in medicine to clinical routine has never been easy. During the second half of the last century, thanks to the progress in chemistry, biochemistry and pharmacology, we have seen the development and the application of a large number of drugs and devices aimed at the treatment of symptoms, blocking unwanted pathways and, in the case of infectious diseases, fighting the micro-organisms responsible. However, we are facing, today, a dramatic change in the therapeutic approach to pathologies and diseases. Indeed, the challenge of the present and the next decade is to fully restore the physiological status of the diseased organism and to completely regenerate tissue and organs when they are so seriously affected that treatments cannot be limited to the repression of symptoms or to the repair of damage. This is being made possible thanks to the major developments made in basic cell and molecular biology, including stem cell science, growth factor delivery, gene isolation and transfection, the advances in bioengineering and nanotechnology, including development of new biomaterials, biofabrication technologies and use of bioreactors, and the big improvements in diagnostic tools and imaging of cells, tissues and organs.
In today`s world, an enhancement of communication between multidisciplinary experts, together with the promotion of joint projects and close collaborations among scientists, engineers, industry people, regulatory agencies and physicians are absolute requirements for the success of any attempt to develop and clinically apply a new biological therapy or an innovative device involving the collective use of biomaterials, cells and/or bioactive molecules. “Frontiers in Bioengineering and Biotechnology” aspires to be a forum for all people involved in the process by bridging the gap too often existing between a discovery in the basic sciences and its clinical application.
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